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Who Needs A Person Responsible for Regulatory Compliance?

PRRC: Who is responsible for the regulatory compliance?

With the possibility to register in EUDAMED, the question of the “Person Responsible for Regulatory Compliance” (PRRC) according to MDR Article 15 also arises.

This function only needs to be provided for manufacturers and EU Authorised Representatives. Importers do not need to provide it. From a German perspective, the PRRC replaces the safety officer from the past, even if the rights and obligations are not directly transferable. Especially in smaller companies, there is often a lack of qualified people.

The required expertise is to be proven in the sense of the MDR as follows:

  • a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

or

  • b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

To avoid to jeopardising the continued existence as a medical device company, external responsible parties may be used. As the title suggests, there is a great deal of responsibility involved. In our opinion, blind trust is not sufficient to take action here.
All of this is for your own protection, as especially for Class I products the reassurance by the Notified Body is missing.

  If you want to know more about our service regarding the “Person Responsible for Regulatory Compliance” contact us.

 

 

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